Pipeline · Six indications
One platform. Six trials.
Six Phase II trials active across PTSD (NYU Langone, UNMC), SAD (NYU Langone), OUD (UCLA, Yale), and smoking cessation (UCLA), with childhood epilepsy and Alzheimer's programs in plan finalization. Lead readout from NYU Langone PTSD expected Q1 2026.
Portfolio map
The whole pipeline at a glance.
| Indication / asset | Stage | Next readout |
|---|---|---|
| Post-traumatic stress disorder Nantheia™ ATL5 | Q1 2026 | |
| Social anxiety disorder Nantheia™ A1002 | Q1 2026 | |
| Opioid use disorder Nantheia™ ATL5 | Q3 2026 | |
| Smoking cessation Nantheia™ ATL5 | Q4 2026 | |
| Childhood epilepsy Nantheia™ ATL5 | 2027+ | |
| Alzheimer's disease Nantheia™ ATL5 | 2027+ |
01 · Nantheia™ ATL5
Phase IIPost-traumatic stress disorder.
Lead program. Two randomized double-blind placebo-controlled Phase II trials (NYU Langone N=87, recruitment complete; University of Nebraska Medical Center N=140, in progress with 77 randomized). CAPS-5 primary endpoint, 8-week dosing. Multi-center pivotal trial (N=350) initiation Q4 2026; NDA filing Q3 2028.
- Design
- RCT, double-blind, placebo-controlled
- Primary endpoint
- CAPS-5 (FDA-approved)
- Dosing period
- 8 weeks
- Sites
- NYU Langone + UNMC
- Investigators
- Marmar, Blessing, Simon, Ross (NYU) · Rizzo (UNMC)
- Status
- NYU recruitment complete · UNMC enrolling
Development stage
02 · Nantheia™ A1002
Phase IIaSocial anxiety disorder.
NIH-funded investigator-sponsored randomized controlled Phase IIa trial at NYU Langone, led by Naomi Simon, MD. Primary endpoint: Trier Social Stress Test (TSST). 21-day treatment duration. Phase II initiation planned Q4 2026 under NIH R33 grant.
- Design
- Randomized controlled trial
- Primary endpoint
- Trier Social Stress Test (TSST)
- Treatment duration
- 21 days
- Site
- NYU Langone
- Principal investigator
- Naomi Simon, MD
- Status
- Phase IIa readout Q1 2026
Development stage
03 · Nantheia™ ATL5
Phase IIOpioid use disorder.
Two NIH-funded investigator-sponsored Phase II trials. UCLA (PI: Edythe London) tests cue-induced opioid craving reduction over 28 days, N=40. Yale (PI: Joao P. De Aquino) studies a THC/CBD combination for pain and cue-induced craving in OUD comorbid with chronic pain, N=120. Yale OUD final readout Q3 2026.
- Design
- RCT, NIH-funded · investigator-sponsored
- UCLA endpoint
- Reduction of cue-induced opioid craving
- UCLA duration
- 28 days · PI: Edythe London
- Yale design
- THC/CBD combination · PI: Joao P. De Aquino
- Sites
- UCLA + Yale
- Status
- Both trials enrolling
Development stage
04 · Nantheia™ ATL5
Phase IISmoking cessation.
Investigator-sponsored Phase II trial at UCLA testing CBD's anxiolytic and craving-reduction profile in smoking cessation. Final data readout expected Q4 2026.
- Design
- Randomized controlled · Phase II
- Site
- UCLA
- Investigator
- UCLA neuropsychiatric program
- Status
- Enrolling · readout Q4 2026
Development stage
05 · Nantheia™ ATL5
PreclinicalChildhood epilepsy.
Differentiated PK profile against FDA-approved Epidiolex® (82% higher Cmax in 24-subject 4-way crossover study). De-risked by Epidiolex precedent (>$1B 2025 net sales, $35K/yr WAC). Plan to be finalized Q4 2026; Phase II initiation targeted Q2 2027.
- Foundation
- 24-subject 4-way crossover PK study
- PK advantage
- 82% higher Cmax vs Epidiolex®
- Reference comparator
- Epidiolex® (Jazz Pharmaceuticals)
- Status
- Plan finalization Q4 2026
Development stage
06 · Nantheia™ ATL5
PreclinicalAlzheimer's disease.
Targets neuropsychiatric symptoms in Alzheimer's disease. Provisional patent in progress. Plan to be finalized Q4 2026; Phase II initiation targeted Q4 2026.
- Status
- Plan finalization Q4 2026
- IP
- Provisional patent in progress
- Phase II initiation
- Q4 2026 (targeted)
Development stage